HPLC法测定止咳平喘类中成药中非法添加的10种化学药物  

Determination of 10 Illegally Addedchemical Drugsin Cough and Asthma-Relieving Chinese Traditional Medicine by HPLC

作　　者：刘艳飞 杨静 赵应梅 何建平 张前飞 LIU Yanfei;YANG Jing;ZHAO Yingmei;HE Jianping;ZHANG Qianfei(GuiYangInstituite for Food and Drug Control,Guiyang 550081,China)

机构地区：[1]贵阳市食品药品检验检测中心,贵州贵阳550081

出　　处：《云南化工》2025年第4期78-81,共4页Yunnan Chemical Technology

摘　　要：目的:建立一种科学、快速的高效液相色谱法,用于筛查止咳平喘类中成药中可能非法添加的10种化学药物。方法:采用phenomenex 00G-4435-E0 C_(18)色谱柱(250 mm×φ4.6 mm,5μm);以甲醇-乙腈(体积比1∶1)为流动相A,甲酸铵溶液(取甲酸铵1.68 g→1000 mL,用冰醋酸调节pH至3.7)为流动相B,梯度洗脱;流速:1.0 mL/min;柱温:35℃;进样体积10μL;检测波长:258 nm,同时在190~400 nm进行DAD扫描。结果:10种成分峰型、分离度均良好,在其各自质量浓度范围内线性良好(r>0.999);精密度、重复性、稳定性试验RSD均小于2%;平均加标回收率为98.20%~103.01%,RSD为1.27%~1.81%;15批样品均未检出阳性成分。结论:该方法操作简便、快速、稳定;方法学研究满足相关标准要求;能够有效地用于快速筛查止咳平喘类中成药中的10种非法添加化学药物。Objective:To establish a scientific and rapidhigh performance liquid chromatography(HPLC)method for the determination ofscreening of 10 possible illegally added chemical drugs in Cough and Asthma-Relieving Chinese Traditional Medicine.Method:Performed onphenomenex 00G-4435-E0 C_(18)(250×φ4.6 mm,5μm)chromatographic column,the mobile phase wasmethanol:acetonitrile(1∶1)and ammonium formate solution(1.68 g→1000 mL,adjust pH to 3.7 with glacial acetic acid),gradient elution;Flow rate:1.0 mL/min;Column temperature:35℃;Injection volume:10μL;detection wavelength was 258 nm performing DAD scanning from 190~400 nm.Result:The peak shapes and separation of the 10 components were well,the linearity showed good(r>0.999)in their respective concentration ranges;the RSD of precision,repeatability,and stability tests were all less than 2%;the average recovery rate was 9.20%-103.01%,and the RSD was1.27%-1.81%;nopositive components detected in the 15 batches of samples.Conclusion:This method is easy to operate,fast,and stable;the methodological research meets the relevant standards;it can be effectively used for the rapid determination10 illegally added chemical components in Coughand Asthma-Relieving Chinese Traditional Medicine.

关 键 词：HPLC 中成药 非法添加 化学药物 止咳平喘 快速筛查 

分 类 号：R286[医药卫生—中药学] O657[医药卫生—中医学]